PV

面议

市辖区

刷新时间：2024-02-18

职位描述

Pharmacovigilance Responsible Person for China
Role                   : PV Manager
Work Location: Beijing

Key Responsibilities:
-Establish, operate and maintain the local Pharmacovigilance system for the monitoring of adverse drug reactions
-Oversee the case handling activities of the local vendor; ensure they meet obligations as defined in the vendor contract
oPerform daily compliance check to ensure regulatory timelines are met
oPerform quality control check of vendor cases
oConduct monthly meeting with local vendor to reconcile case volumes, compliance and quality
-Perform case reconciliation with partners, vendors and Emerging Market PV team
-Provide appropriate medical interpretation and consistency to adverse event case assessment
-Monitor local PV mailbox for receipt of adverse event reports and ensure these are forwarded to the Emerging Market PV team for onward processing
-Perform follow up of individual case safety reports, as needed
-Perform aggregate safety data review on an ad hoc basis in order to support safety evaluations and the generation of Annual Summary Reports
-Provide medical input to safety signal management activities (detection, validation, assessment) and batch trend analysis for assigned products
-Serve as the medical expert for benefit-risk evaluations, continuously monitoring the benefit-risk profile of assigned products and ensure implementation and oversight of any local risk minimization activities, as applicable
-Provide medical contribution and review of responses to the regulatory authority
-Identify areas of improvement and propose recommendations to ensure the continued effectiveness of the local Pharmacovigilance system
-Interact with the regulatory authority on Pharmacovigilance matters as needed and act as a point of contact for Pharmacovigilance
-Support local training of non-pharmacovigilance personnel
-Provide input and review vendor manuals/work instructions as necessary
-Support the development of the Dr Reddy’s Quality Management System through the development and maintenance of local procedural documents in accordance with global procedures

Educational Qualification & Experience Required:  
·MD, Pharmacist or Life Scientist degree
· At least 3 years’ experience in Pharmacovigilance at a pharmaceutical/biotechnology company
·Knowledge and understanding of national regulations and guidance for Pharmacovigilance and drug safety practices
·Strong knowledge of individual adverse event case report processing and medical review
·Excellent oral and written communication skills
·Excellent teamwork and interpersonal skills are required
·Knowledge of medical aspects of drug safety in pre- and post-marketing safety practice

其他要求

招聘人数：1人
职能类别：药物安全/药物警戒PV

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。